Hoffrichter CPAP User manual

User‘s Manual
Respiratory Therapy Device
CPAP - AutoCPAP - BILEVEL ST20
as of device software 3.300

2 Info
SERIAL NUMBER
Every HOFFRICHTER GmbH device is supplied with a
serial number for traceability purposes.
Please enter your device‘s serial number here. You will
find the serial number on the rating plate on the back
of the device.
...............................................
Please always quote the serial number for all queries
and complaints.
CONFORMITY
The device complies with the requirements of Directive
93/42/EEC.

Contents 3
CONTENTS
Scope of delivery ................................................... 7
General.................................................................. 8
Information on this user‘s manual........................ 8
Symbols used in this manual ............................... 9
Symbols on the rating plate............................... 11
Safety Information................................................ 12
General safety instructions ................................ 12
Electrical safety................................................. 14
Installation requirements and transport .............. 15
Before commissioning....................................... 17
Using oxygen.................................................... 18
Intended use..................................................... 19
Contraindications .............................................. 21
Side effects....................................................... 22
Device description ............................................... 23
How the device works.......................................... 24
General............................................................. 24
Power supply.................................................... 25
Therapy modes.................................................... 27
CPAP................................................................ 28
APAP ............................................................... 28
BILEVEL S, T and ST ....................................... 33

4 Contents
Using the device .................................................. 37
Commissioning ................................................. 37
Turning on and off in battery mode .................... 39
Standby mode .................................................. 39
Automatic zero point correction .......................... 40
Power failure..................................................... 42
Using oxygen.................................................... 42
Device functions .................................................. 44
Parameters in point 2 CPAP .............................. 47
Parameters in point 2 AutoCPAP....................... 48
Parameter in point 2 BILEVEL ST20 .................. 50
Language ......................................................... 52
P-Unit ............................................................... 52
Operating times ................................................ 53
Date ................................................................. 54
Time ................................................................. 55
Wake up time.................................................... 56
Mode ............................................................... 57
Pressure ........................................................... 58
IPAP ................................................................. 60
EPAP ................................................................ 61
I-Slope.............................................................. 61
E-Slope ............................................................ 62
Frequency......................................................... 64
I:E..................................................................... 65

Contents 5
Delay Time........................................................ 65
Backup freq ...................................................... 66
P-Min................................................................ 67
P-Max............................................................... 68
P-Start.............................................................. 68
I-FLEX............................................................... 69
E-FLEX ............................................................. 70
Calibration ........................................................ 71
Ramp ............................................................... 73
Mask Test ......................................................... 75
Automatic ......................................................... 76
Display Vt ......................................................... 77
Bact.Filter ......................................................... 79
Brightness ........................................................ 80
Parameter settings............................................ 81
Alarm functions of the device ............................... 83
Mask alarm....................................................... 83
Pressure alarm.................................................. 83
Wake up alarm.................................................. 84
Important display messages................................. 85
Using an SD card................................................. 87
General information........................................... 87
Inserting the SD card ........................................ 88
Removing the SD card ...................................... 89
What is saved on the SD card ........................... 90

6 Contents
Error messages................................................. 92
Changing the filter, cleaning.................................. 94
Cleaning the mask ............................................ 96
Cleaning the therapy tube ................................. 96
Cleaning the device........................................... 97
Cleaning the headgear ...................................... 98
Cleaning the humidifier...................................... 98
Preparing the device for a patient change............. 99
Using bacterial filters .......................................... 100
Troubleshooting ................................................. 101
Maintenance ...................................................... 103
Disposal............................................................. 104
Device ............................................................ 104
Packaging....................................................... 104
Accessories .................................................... 104
Accessories ....................................................... 105
Technical data.................................................... 107
Manufacturer’s declaration on electromagnetic
compatibility ...................................................... 111
Disclaimer.......................................................... 116

Scope of delivery 7
SCOPE OF DELIVERY
1 Respiratory therapy device point 2 1
2 Mains cable
3 Power supply
4 Therapy tube (ID = 22 mm, length = 1.80 m)
5 Ventilation mask (optional) with exhalation valve
Different sorts of mask systems are available.
6 Headgear
7 User‘s manual
8 Brief instructions
9 Spare filter (2 pack)
10 Carrying case
1
1 1 optional equipment variant for use with humidifier
3
12
4
5
6
7
8
10
9

8 General
GENERAL
INFORMATION ON THIS USER‘S MANUAL
Read this user‘s manual through carefully before using
your therapy device for the first time.
Follow the safety and cleaning instructions in particular.
Keep the manual in a safe place close to the device so
that you can refer to it immediately if necessary.

General 9
SYMBOLS USED IN THIS MANUAL
Important information is denoted by symbols in this
user‘s manual. Be sure to follow these instructions in
order to avoid accidents, personal injury and mate-
rial damage.
This symbol denotes general safety instructions.
Follow these instructions to avoid accidents, per-
sonal injury or material damage.
This symbol denotes hazardous situations that
lead to serious injuries or death.
This symbol denotes hazardous situations that
may lead to serious injuries or death.
This symbol denotes hazardous situations that
may lead to moderately severe injuries.

10 General
This symbol denotes situations that may lead to
material damage or damage to the device.
This symbol denotes information, tips and instruc-
tions for efficient, error-free use of the device.
In addition, the local accident prevention regulations
and general safety regulations in force in the area of
use must be observed.

General 11
SYMBOLS ON THE RATING PLATE
Observe the warning and safety instruc-
tions in the user‘s manual.
BF application part
Protection class II (protective insulation)
CE conformity declaration
Manufacturer
Serial number
Follow the user‘s manual.
Do not dispose of the device in the house-
hold waste. Please contact the relevant cus-
tomer services department to find out how
to dispose of the device properly.

12 Safety Information
SAFETY INFORMATION
GENERAL SAFETY INSTRUCTIONS
• Only use the device for your own
CPAP therapy prescribed by the
physician.
•
Only use accessories and spare
parts approved by us for use with
the device.
•Only use the mask and therapy tube
for your own therapy.
• Observe the mask manufacturer‘s
usage instructions.
• Check that the exhalation opening in
the mask is not obstructed.
• Make sure you use an exhalation valve
if the mask has no exhalation opening.
• Inform your specialist dealer imme-
diately if the device is not working
properly.

Safety Information 13
• Please see your physician immedi-
ately if dryness of the mucous mem-
branes in the nose and throat, sinus
discomfort, ear ache, runny nose,
over sensitive reactions of the skin,
irritabilities, loss of voice, orientation
or memory impairment occur when
using the device.

14 Safety Information
ELECTRICAL SAFETY
•Do not use the device if its housing,
cables or power supply are damaged.
• Do not open the device housing
under any circumstances. Inform
your specialist dealer if the device
develops a fault.
• During therapy, do not connect any
other line-powered devices via the
RS232 interface at the rear of the
device.
• Protect the device from water and
dampness.
• Always unplug the device from the
mains before cleaning.
• Empty and thoroughly clean any
optional humidifier if you do not plan
to use it for a lengthy period of time.

Safety Information 15
INSTALLATION REQUIREMENTS AND
TRANSPORT
• Place the device near your bed on
a firm and level surface. A bedside
cabinet is ideally suited for this.
•During therapy, the device must not
be operated in a drawer, on a closet
shelf or behind a partition.
•
It must be ensured that the air inlet at
the rear of the device is accessible at
all times and not obstructed. Drapes,
curtains, paper or other objects must
not be located behind the device.
•Do not place the device on the floor
or under the bed in order to maintain
low dust exposure levels.
• Do not put the device close to a
source of heat.
• Avoid setting up the device at loca-
tions where it will be exposed to direct
sunlight.

16 Safety Information
• Make sure you operate the device
at a sufficient distance from other
equipment which could emit electro-
magnetic waves such as diathermy
devices, cell phones, remote-con-
trolled toys and microwave appli-
ances.
• Empty the humidifier (optional acces-
sory) before packing it away in the
carrying case.

Safety Information 17
BEFORE COMMISSIONING
•Do not switch the device on if it has
previously been in a very cold environ-
ment. Wait for about one hour for the
temperature to balance out.
•
Check for proper setup and proper
condition of the device.
• Check the condition of the breathing
tube, mask, humidifier and air filter.
Special attention should be paid to
the maintenance instructions.

18 Safety Information
USING OXYGEN
• Oxygen supports combustion. There-
fore, observe the fire protection regu-
lations applicable for using oxygen.
•
Ensure that there is no grease on the
oxygen fittings. Do not smoke and
do not handle naked flames.
• Before using any oxygen equipment
for the first time, you must receive
instruction from your specialist dealer
in your home environment.
• Be sure to observe the user‘s manual
of the manufacturer or distributor
from whom you obtain the oxygen.
• Have your distributor advise you
about the use of oxygen.
•In any case, follow your physician‘s
instructions.

Safety Information 19
INTENDED USE
The point 2 is a respiratory therapy device designed
for the treatment of sleep-related breathing disorders
in patients weighing 30 kg or more. With increased
demand of pressure and/or forms of respiratory insuf-
ficiency, the point 2 BILEVEL ST20 offers the classical
non-invasive ST-Bilevel therapy. The device is designed
for non-dependent ventilated patients in the home
therapy, who need a respiratory support with backup
frequency.
The point 2 CPAP (CPAP = Continuous Positive Airway
Pressure) is a respiratory therapy device, which applies
a continuous positive airway pressure to the patient.
The point 2 AutoCPAP (AutoCPAP = Automatically
Adjusting Continuous Positive Airway Pressure) is a
respiratory therapy device, which provides an event-
driven therapy pressure adjustment within preset pres-
sure limits.
The 2 BILEVEL ST20 (ST = Spontaneous, Timed) is a
respiratory therapy device, which enables two indepen-
dently adjustable pressure levels depending of inspira-
tion and expiration.
The device generates positive airway pressure which
keeps the patient‘s airways open whilst asleep. The

20 Safety Information
therapy pressure is administered via a respiratory mask
(nasal, nasal cushion or full-face mask), which must
be fitted with an exhalation valve to ensure that the
exhaled air is discharged.
The point 2 is designed for use at home, in hospitals
and for portable operation.
The device is not suitable for use with patients in need
of artificial respiration.
This therapy device is no life-support system.